NCT00963521已完成1 期
Pilot Study of Therapeutic Vaccination by Leukemic Blasts in Vitro Differentiated Dendritic Cells From Patients With Acute Myelogenous Leukemia in Complete Remission
Institut Paoli-Calmettes2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2008年6月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Adverse events at 6 months
研究概览
简要总结
RATIONALE: Vaccines made from dendritic cells may help the body build an effective immune response to kill cancer cells.
PURPOSE: This phase I trial is studying the side effects of vaccine therapy and to see how well it works in treating patients with acute myeloid leukemia in complete remission.
详细描述
OBJECTIVES:
Primary
- Assess the tolerability of autologous dendritic cell vaccine in patients with acute myelogenous leukemia in complete remission.
Secondary
- Evaluate the emergence of an immune response.
- Determine the relapse rate.
- Assess the occurrence of residual disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Diagnosis of acute myelogenous leukemia (AML)
- •Myelomonocytic (M4) or monocytic (M5) subtype
- •In second complete remission (CR) or later following CR1 lasting ≤ 12 months after chemotherapy that may have included an intensification regimen followed by autologous transplantation
- •No (15;17) translocation
- •No AML M3
- •HLA-A2 positivity
- •CD14 ≥ 20% on peripheral blood mononuclear cells
- •Circulating blasts ≥ 10 x 109/L (collected prior to chemotherapy) available
- •Must not be eligible for HLA-matched allogeneic transplantation
- •No progressive disease
- •PATIENT CHARACTERISTICS:
- •Karnofsky performance status 70-100%
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •No contraindication to cytopheresis or chemotherapy
- •No HIV or HTLV positivity
- •No hepatitis B or C activation
- •No prior psychological disease
- •Not deprived of liberty and able to give consent
- •Must be able to speak and read French
- •No other cancer except for basal cell or cervical
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •No concurrent participation in another clinical study
排除标准
- 未提供
结局指标
主要结局
Adverse events at 6 months
次要结局
未报告次要终点
研究者
研究点 (2)
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